Trial Comparing Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia
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| ClinicalTrials.gov Identifier: NCT00566332 |
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Recruitment Status :
Completed
First Posted : December 3, 2007
Last Update Posted : August 19, 2015
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Waldenström's macroglobulinaemia (WM) is a lymphoproliferative disorder characterized by a monoclonal IgM paraprotein and morphological evidence of lymphoplasmacytic lymphoma: the cells are IgM+, IgD+, CD19+ and CD20+ but usually CD5-, CD10- and CD23-. The treatment efficacy is difficult to assess because of the lack of clear diagnostic criteria , good response criteria, and of randomized trials.
The actual treatment is Chlorambucil, an alkylating agent. A purine analogue such as Fludarabine has proven its efficacy on 30 % to 80 % as first line therapy
This study is a phase II b open, prospective, international multicenter trial (England, Dr Johnson, Dr Catovsky, Australia: Dr Seymour) promoted by the French Cooperative Group on Chronic Lymphoid Leukemia in untreated WM, or closely related disorders ( Lymphoplasmacytic lymphoma or splenic marginal zone lymphoma). 366 patients must be included, among them 180 patients in France. Patients will be stratified according to the lymphoproliferative disorder.
The patients will receive Chlorambucil by oral route for 10 days every 28 days (12 cycles) (8 MG/M², 6 MG/M² if patient is more than 75 years old) or Fludarabine by oral route for 5 days every 28 days (6 cycles) (40MG/M², 30 MG/M² if patient is more than 75 years old).
The primary objective is to compare the efficacy (response rate) of Chlorambucil to Fludarabine in previously untreated patients. The secondary objectives are the duration of response, the improvement of hematological parameters, the toxicity, the quality of life, the event free survival and the overall survival.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Waldenström Macroglobulinemia Lymphoplasmacytic Lymphoma Splenic Marginal Zone Lymphoma | Drug: Chlorambucil Drug: Fludarabine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 414 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Trial Comparing the Efficacy of Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia,Lymphoplasmacytic Lymphoma or Splenic Marginal Zone Lymphoma |
| Study Start Date : | June 2001 |
| Actual Primary Completion Date : | September 2009 |
| Actual Study Completion Date : | December 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Chlorambucil 8mg/m² (6 mg/m² if patient aged more than 75 years old) 10 days every 28 days during 12 months
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Drug: Chlorambucil
Chlorambucil 8 mg/m² (6 mg/m² if patient aged more than 75 years old) 10 days every 28 days during 12 months By oral route |
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Active Comparator: 2
Fludarabine
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Drug: Fludarabine
Fludarabine 40 mg/m² (30 mg/m² if patient aged more than 75 years old) 5 days every 28 days during 6 cycles By oral route |
- Patient overall response [ Time Frame: At the end of treatment whether 6 or 12 months ]
- Biological study [ Time Frame: Whether 6 or 12 months ]
- Quality of life [ Time Frame: Whether 6 or 12 months ]
- Response duration [ Time Frame: 60 months ]
- Treatment toxicity [ Time Frame: 60 months ]
- Event free survival [ Time Frame: 60 months ]
- Overall survival [ Time Frame: 60 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Established diagnosis of Waldenström macroglobulinemia (the 2nd Workshop on Waldenstrom's macroglobulinemia) or Lymphoplasmacytic lymphoma or Splenic Marginal Zone Lymphoma, needing a treatment
- Life expectancy > 6 months
- Creatinine < 200 µmol/l
- SGPT and SGOT < 2x ULN
- A negative direct Coombs test
- Written informed consent
Exclusion Criteria:
- Past chemotherapy/radiotherapy/immunotherapy prior to the study for Waldenström macroglobulinemia
- Previous malignancy less than 5 years ago except carcinoma in situ of the cervix and non-melanoma skin cancer
- Positive HIV serology
- Active Hepatitis B or C
- Lactation/pregnancy
- Impossible good compliance with the study protocol
- Active infection not controlled
- Psychological condition hampering understanding of the study
- Transformation into large B cell lymphoma
- Peripheral neuropathy > grade II
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566332
| France | |
| Hôpital La Pitié-Salpêtrière. 47-83 Bd de l'hôpital | |
| Paris, France, 75013 | |
| Principal Investigator: | Véronique LEBLOND, Professor | French Study Group on Chronic Lymphoid Leukemia |
| Responsible Party: | French Study Group on Chronic Lymphoid Leukemia |
| ClinicalTrials.gov Identifier: | NCT00566332 |
| Other Study ID Numbers: |
WM1 |
| First Posted: | December 3, 2007 Key Record Dates |
| Last Update Posted: | August 19, 2015 |
| Last Verified: | August 2015 |
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Waldenström Macroglobulinemia Lymphoplasmacytic lymphoma Splenic Marginal Zone Lymphoma Fludarabine Chlorambucil |
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Lymphoma Lymphoma, B-Cell, Marginal Zone Waldenstrom Macroglobulinemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin Neoplasms, Plasma Cell Hemostatic Disorders |
Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Fludarabine Chlorambucil Antineoplastic Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |